We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Assessment of the Implementation of the ResQGARD® Impedance Threshold Device by the San Antonio Fire Department

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01780350
First Posted: January 31, 2013
Last Update Posted: February 27, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Advanced Circulatory Systems
  Purpose
This study is attached to a comprehensive quality assurance/quality improvement (QA/QI) program conducted by the Office of the medical director, and is designed to contribute to generalizable knowledge to determine effectiveness and tolerability of an FDA approved Impedance Threshold Device (ITD) device in a large urban emergency medical service (EMS) system. The cohort will comprise a convenience sample of patients that are being treated by EMS for a hypotensive emergency.

Condition Intervention Phase
Acute Hypotension Device: ResQGARD ITD Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Further study details as provided by Advanced Circulatory Systems:

Primary Outcome Measures:
  • Change in Systolic Blood Pressure From Baseline (Before ITD Use) [ Time Frame: During device use, up to 1 hour ]
    Determining whether the application of an ITD will provide improvement in systolic blood pressure in subjects with hypotension in patients being treated by San Antonio EMS when compared to baseline.


Secondary Outcome Measures:
  • Tolerability [ Time Frame: Duration of device use, up to 1 hour ]
    Determine patient tolerability of the device while breathing through it. This is subjectively measured by the paramedic administering the device based on verbal reporting from the patient and paramedic estimation of the patient response to the device.


Enrollment: 200
Study Start Date: April 2012
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ResQGARD ITD
Subjects receive a ResQGARD ITD.
Device: ResQGARD ITD
Patients eligible for the device will receive the ResQGARD attached to a facemask or mouthpiece. The patient will use the device, provided it is tolerated, until their blood pressure is stabilized as determined by EMS personnel.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adults between the ages of 18-120 years
  • presenting to EMS with or development of Hypotension during EMS interaction
  • treated by EMS with the ITD

Exclusion Criteria:

  • pediatric patients
  • patients that do not present with or develop hypotension
  • patients who the ITD will not form a secure seal due to anatomical abnormalities
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Advanced Circulatory Systems
ClinicalTrials.gov Identifier: NCT01780350     History of Changes
Other Study ID Numbers: W81XWH-BAA-11-1
First Submitted: July 19, 2012
First Posted: January 31, 2013
Results First Submitted: February 12, 2015
Results First Posted: February 27, 2015
Last Update Posted: February 27, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
Hypotension
Vascular Diseases
Cardiovascular Diseases